Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/…

Recall date
April 22, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2332-2020
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
Worldwide

Why it was recalled

A manufacturing error resulted in out of specification R3 Acetabular Shells

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264 Orthopedic implant component.

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